How To Ensure Local-Level Pharmacovigilance Compliance And Efficiency

In the field of pharmacovigilance (PV) and risk management, change is the only constant. Companies must continually diversify to adapt to evolving regulations and technologies. Some countries may legally require the presence of a local qualified person for PV (QPPV), while some do not. Others may require access to a local PV system master file or for PV submissions to be provided in the local language. Beyond meeting compliance standards, pharmaceutical companies must implement the quality systems necessary to handle data in the local language, ensure data privacy, and minimize risk.

Due to the number of local affiliates attached to global companies, ensuring standardization and compliance can be difficult. Though it may seem daunting and costly, there are existing frameworks and technologies that can assist companies as they navigate the choppy waters of local affiliate PV. Download this article to explore how AI-translation, automated redaction, and a greater understanding of local affiliate challenges can help you develop systems that better support PV compliance and collaboration.